{"id":"https://openalex.org/W7204262730","doi":"https://doi.org/10.1109/icdh72779.2026.00044","title":"From Regulatory Text to Executable Constraints: Operationalising Compliance for Medicine Labelling","display_name":"From Regulatory Text to Executable Constraints: Operationalising Compliance for Medicine Labelling","publication_year":2026,"publication_date":"2026-07-01","ids":{"openalex":"https://openalex.org/W7204262730","doi":"https://doi.org/10.1109/icdh72779.2026.00044"},"language":"en","primary_location":{"id":"doi:10.1109/icdh72779.2026.00044","doi":"https://doi.org/10.1109/icdh72779.2026.00044","is_oa":true,"landing_page_url":"https://doi.org/10.1109/icdh72779.2026.00044","pdf_url":null,"source":{"id":"https://openalex.org/S7407088867","display_name":"IEEE International Conference on Digital Health (ICDH)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"conference"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2026 IEEE International Conference on Digital Health (ICDH)","raw_type":"proceedings-article"},"volume":null,"type":"conference-paper","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://doi.org/10.1109/icdh72779.2026.00044","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5139701549","display_name":"Frank Tran","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I31746571","display_name":"UNSW Sydney","ror":"https://ror.org/03r8z3t63","country_code":"AU","type":"education","lineage":["https://openalex.org/I31746571"]}],"countries":["AU"],"is_corresponding":false,"raw_author_name":"Frank Tran","raw_affiliation_strings":["Computer Science and Engineering University of New South Wales"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Computer Science and Engineering University of New South Wales","institution_ids":["https://openalex.org/I31746571"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5148267238","display_name":"Paul Benjamin Ramirez","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Paul Benjamin Ramirez","raw_affiliation_strings":["Automi Sydney"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Automi Sydney","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5148194969","display_name":"Vinesh George","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Vinesh George","raw_affiliation_strings":["Automi Sydney"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Automi Sydney","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5138211775","display_name":"Aditya Joshi","orcid":"https://orcid.org/0000-0003-2200-9703","observed_orcids":["https://orcid.org/0000-0003-2200-9703"]},"institutions":[{"id":"https://openalex.org/I31746571","display_name":"UNSW Sydney","ror":"https://ror.org/03r8z3t63","country_code":"AU","type":"education","lineage":["https://openalex.org/I31746571"]}],"countries":["AU"],"is_corresponding":false,"raw_author_name":"Aditya Joshi","raw_affiliation_strings":["Computer Science and Engineering University of New South Wales"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Computer Science and Engineering University of New South Wales","institution_ids":["https://openalex.org/I31746571"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5124299265","display_name":"Hye-Young Helen Paik","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I31746571","display_name":"UNSW Sydney","ror":"https://ror.org/03r8z3t63","country_code":"AU","type":"education","lineage":["https://openalex.org/I31746571"]}],"countries":["AU"],"is_corresponding":false,"raw_author_name":"Hye-young Paik","raw_affiliation_strings":["Computer Science and Engineering University of New South Wales"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Computer Science and Engineering University of New South Wales","institution_ids":["https://openalex.org/I31746571"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5059077090","display_name":"Salil S. Kanhere","orcid":"https://orcid.org/0000-0002-1835-3475","observed_orcids":["https://orcid.org/0000-0002-1835-3475"]},"institutions":[{"id":"https://openalex.org/I31746571","display_name":"UNSW Sydney","ror":"https://ror.org/03r8z3t63","country_code":"AU","type":"education","lineage":["https://openalex.org/I31746571"]}],"countries":["AU"],"is_corresponding":false,"raw_author_name":"Salil Kanhere","raw_affiliation_strings":["Computer Science and Engineering University of New South Wales"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Computer Science and Engineering University of New South Wales","institution_ids":["https://openalex.org/I31746571"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.65626573,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"324","last_page":"330"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13643","display_name":"Artificial Intelligence in Law","score":0.6309000253677368,"subfield":{"id":"https://openalex.org/subfields/3308","display_name":"Law"},"field":{"id":"https://openalex.org/fields/33","display_name":"Social Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T13643","display_name":"Artificial Intelligence in Law","score":0.6309000253677368,"subfield":{"id":"https://openalex.org/subfields/3308","display_name":"Law"},"field":{"id":"https://openalex.org/fields/33","display_name":"Social Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T13295","display_name":"Safety Systems Engineering in Autonomy","score":0.07530000060796738,"subfield":{"id":"https://openalex.org/subfields/2213","display_name":"Safety, Risk, Reliability and Quality"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.059700001031160355,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/regulatory-compliance","display_name":"regulatory compliance","score":0.6959999799728394},{"id":"https://openalex.org/keywords/deontic-modality","display_name":"deontic modality","score":0.6370000243186951},{"id":"https://openalex.org/keywords/over-the-counter-drugs","display_name":"over-the-counter drugs","score":0.6309999823570251},{"id":"https://openalex.org/keywords/prescription-drugs","display_name":"prescription drugs","score":0.8429999947547913}],"concepts":[{"id":"https://openalex.org/C2781460075","wikidata":"https://www.wikidata.org/wiki/Q1399332","display_name":"Compliance (psychology)","level":2,"score":0.6953999996185303},{"id":"https://openalex.org/C160145156","wikidata":"https://www.wikidata.org/wiki/Q778586","display_name":"Executable","level":2,"score":0.5741999745368958},{"id":"https://openalex.org/C2780523633","wikidata":"https://www.wikidata.org/wiki/Q380709","display_name":"Labelling","level":2,"score":0.5570999979972839},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.46480000019073486},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.39890000224113464},{"id":"https://openalex.org/C39549134","wikidata":"https://www.wikidata.org/wiki/Q133080","display_name":"Public relations","level":1,"score":0.35440000891685486},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.3336000144481659},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.32170000672340393},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.305400013923645},{"id":"https://openalex.org/C26517878","wikidata":"https://www.wikidata.org/wiki/Q228039","display_name":"Key (lock)","level":2,"score":0.30480000376701355},{"id":"https://openalex.org/C198352243","wikidata":"https://www.wikidata.org/wiki/Q37105","display_name":"Line (geometry)","level":2,"score":0.3046000003814697},{"id":"https://openalex.org/C18762648","wikidata":"https://www.wikidata.org/wiki/Q42213","display_name":"Work (physics)","level":2,"score":0.3019999861717224},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.2906999886035919},{"id":"https://openalex.org/C108827166","wikidata":"https://www.wikidata.org/wiki/Q175975","display_name":"Internet privacy","level":1,"score":0.26899999380111694},{"id":"https://openalex.org/C2776401178","wikidata":"https://www.wikidata.org/wiki/Q12050496","display_name":"Feature (linguistics)","level":2,"score":0.2581000030040741},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.2549000084400177},{"id":"https://openalex.org/C184356942","wikidata":"https://www.wikidata.org/wiki/Q830382","display_name":"Best practice","level":2,"score":0.2524999976158142}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1109/icdh72779.2026.00044","doi":"https://doi.org/10.1109/icdh72779.2026.00044","is_oa":true,"landing_page_url":"https://doi.org/10.1109/icdh72779.2026.00044","pdf_url":null,"source":{"id":"https://openalex.org/S7407088867","display_name":"IEEE International Conference on Digital Health (ICDH)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"conference"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2026 IEEE International Conference on Digital Health (ICDH)","raw_type":"proceedings-article"}],"best_oa_location":{"id":"doi:10.1109/icdh72779.2026.00044","doi":"https://doi.org/10.1109/icdh72779.2026.00044","is_oa":true,"landing_page_url":"https://doi.org/10.1109/icdh72779.2026.00044","pdf_url":null,"source":{"id":"https://openalex.org/S7407088867","display_name":"IEEE International Conference on Digital Health (ICDH)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"conference"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2026 IEEE International Conference on Digital Health (ICDH)","raw_type":"proceedings-article"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":14,"referenced_works":["https://openalex.org/W1934602670","https://openalex.org/W1988634903","https://openalex.org/W2104400119","https://openalex.org/W2791213314","https://openalex.org/W2794085611","https://openalex.org/W2807453632","https://openalex.org/W2960053204","https://openalex.org/W2971590111","https://openalex.org/W3204040572","https://openalex.org/W4378697700","https://openalex.org/W4382318094","https://openalex.org/W4391778638","https://openalex.org/W4402340189","https://openalex.org/W4404340680"],"related_works":["https://openalex.org/W7053259470","https://openalex.org/W7168277528","https://openalex.org/W2238175325","https://openalex.org/W7204258113","https://openalex.org/W7208003059","https://openalex.org/W6885050707","https://openalex.org/W7214582376","https://openalex.org/W2431691112","https://openalex.org/W7071695440","https://openalex.org/W2419271465"],"abstract_inverted_index":{"Regulatory":[0],"requirements":[1,30,112,131,155,184,191,220],"governing":[2],"safety-critical":[3],"health":[4],"domains,":[5],"such":[6,29],"as":[7,38,90],"medicine":[8,53],"labelling,":[9],"are":[10,31,63,81,157,193,221],"predominantly":[11],"expressed":[12],"in":[13,42,132,139],"legal":[14],"prose":[15],"with":[16,196],"strong":[17],"deontic":[18],"modality":[19],"(e.g.,":[20],"obligations":[21],"and":[22,67,76,96,109,117,135,186,232,247,256],"prohibitions).":[23],"While":[24],"suitable":[25],"for":[26,241,253],"human":[27],"interpretation,":[28],"not":[32,222],"directly":[33,158],"machine-interpretable,":[34],"limiting":[35],"their":[36],"use":[37],"deterministic,":[39],"executable":[40,58,91],"constraints":[41,92],"label":[43],"design":[44,94],"workflows.":[45],"We":[46,102,142],"introduce":[47,144],"a":[48,145,161,212,251],"machine-verifiable":[49],"methodology":[50,105],"that":[51,72,156,167,179],"operationalises":[52],"labelling":[54,111],"regulations":[55,87],"into":[56,69,83],"structured,":[57],"compliance":[59],"contracts.":[60],"Legal":[61],"provisions":[62],"systematically":[64],"extracted,":[65],"filtered,":[66],"translated":[68],"normative":[70],"representations":[71,80],"specify":[73],"content,":[74],"structural,":[75],"format":[77],"constraints.":[78,175],"These":[79,236],"compiled":[82],"deterministic":[84],"checks,":[85],"enabling":[86],"to":[88],"serve":[89],"on":[93,169,228],"artefacts":[95],"supporting":[97],"systematic":[98],"analysis":[99,177],"of":[100,148,182,188,206,215,244,259],"compliance.":[101],"instantiate":[103],"the":[104,151,197,207,239],"using":[106],"U.S.":[107],"Over-the-counter":[108],"Prescription":[110],"(21":[113],"CFR":[114,119],"\u00a7":[115,120],"201.66":[116],"21":[118],"201.100).":[121],"Under":[122],"this":[123],"process,":[124],"we":[125],"operationalise":[126],"16":[127],"from":[128,137,165],"81":[129],"design-related":[130],"OTC":[133,183],"regulations,":[134],"7":[136],"12":[138],"prescription":[140,190],"regulations.":[141],"further":[143],"tiered":[146],"notion":[147],"evaluability":[149],"over":[150],"operationalised":[152,189],"subset,":[153],"distinguishing":[154],"artefact-evaluable":[159],"under":[160],"structured":[162],"SVG":[163],"representation":[164,174],"those":[166],"depend":[168],"unresolved":[170],"product":[171,229,248],"context":[172],"or":[173,203],"Our":[176],"reveals":[178],"only":[180],"7.4%":[181],"(6/81)":[185],"16.7%":[187],"(2/12)":[192],"fully":[194],"automatable,":[195],"majority":[198],"requiring":[199],"additional":[200],"product-context":[201],"modelling":[202,243],"information":[204],"outside":[205],"regulation":[208],"document.":[209],"This":[210],"exposes":[211],"fundamental":[213],"limitation":[214],"artefact-level":[216],"evaluation:":[217],"many":[218],"regulatory":[219,234],"intrinsically":[223],"evaluable":[224],"without":[225],"resolving":[226],"dependencies":[227],"context,":[230,249],"representation,":[231],"external":[233],"sources.":[235],"findings":[237],"highlight":[238],"need":[240],"joint":[242],"artefact":[245],"structure":[246],"providing":[250],"foundation":[252],"scalable,":[254],"auditable,":[255],"trustworthy":[257],"validation":[258],"generative":[260],"healthcare":[261],"artefacts.":[262]},"counts_by_year":[],"updated_date":"2026-11-08T12:12:28.789561","created_date":"2026-08-27T00:00:00"}